Status:
COMPLETED
Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
Lead Sponsor:
Anderson Orthopaedic Research Institute
Collaborating Sponsors:
University of Western Ontario, Canada
DePuy Orthopaedics
Conditions:
Non-inflammatory Degenerative Joint Disease
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a c...
Eligibility Criteria
Inclusion
- Undergoing cementless primary total hip replacement
- Receiving acetabular cup of 52mm or greater
- Preoperative level of function and pain same as for conventional hip replacement
- Likelihood of obtaining relief of pain and improved function
- Full skeletal maturity
- Ability to follow instructions
- Good general health
- Willing to return for follow-up evaluations
- X-ray evaluation confirming the presence of NIDJD
- Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants
Exclusion
- Age less than 40 years or greater than 80 years at time of surgery
- Patients templated to receive an acetabular component smaller than 52mm in diameter
- Presence of a previous prosthetic hip replacement device in the hip joint to be operated
- Previous girdlestone procedure or surgical fusion of the hip to be operated
- Acute femoral neck fracture
- Above knee amputation of the contralateral and/or ipsilateral leg
- Patients with a diagnosis of inflammatory degenerative arthritis
- Skeletally immature
- Evidence of active infections that may spread to other areas of the body
- The presence of a highly communicable disease that may limit follow-up
- Presence of known active metastatic or neoplastic disease
- Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
- Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
- Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
- Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
- Any steroid therapy, local or systemic, within three months prior to surgery
- Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
- Patient has known allergies to metal, e.g., jewelry
- Any patient not meeting all radiographic and clinical parameters for inclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00962351
Start Date
October 1 2003
End Date
October 1 2013
Last Update
August 17 2015
Active Locations (2)
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1
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22306
2
Department of Orthopaedic Surgery, University of Western Ontario
London, Ontario, Canada, N6A5A5